Drug application

CABOMETYX (CABOZANTINIB S-MALATE)

Drugs@FDA NDA 208692 · EXELIXIS INC

Key facts

Drug name CABOMETYX
Active ingredients CABOZANTINIB S-MALATE
Application type NDA
Application number 208692
Company EXELIXIS INC
Dosage forms TABLET, ORAL
Strength EQ 20MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Apr 25, 2016

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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